BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOTICA HIDROCOR LENSES

    MDR report key: 12137417 · Received July 7, 2021

    Report

    Report Number
    MW5102380
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    July 5, 2021
    Report Date
    July 6, 2021
    Manufacturer
    SOLOTICA INDUSTRIA E COMERCIO LTDA
    Product Code
    LPL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I SOAKED SOLOTICA CONTACT LENSES IN WATER FOR 24 HOURS THEN I WASH MY HANDS AND CLEAN THEM WITH THE SAME SOLUTION "RENU SOLUTION" I COULD NOT WEAR THEM AND I REMOVE THEM QUICKLY. IT IS LIKE SOMETHING BURNING IN MY EYES AND CAUSED ITCHINESS. NEXT DAY, I WOKE WITH EYES FULL OF EYE SORES, DRYNESS AND ITCHINESS. I BOUGHT 3 PAIRS FOR MY RELATIVES AND I AS WE USED TO WEAR SOLOTICA YEARLY CONTACT LENSES AND THE LAST TIME WAS IN 2017 AS IT IS FDA APPROVED. NOWADAYS, I BELIEVE THAT THE QUALITY HAS BEEN TOTALLY CHANGED. I ALSO CHECKED PEOPLE'S REVIEWS ON (B)(6) AND ON MANY WEBSITES TO FIND OUT THAT I AM NOT THE ONLY ONE WHO HAD THE ISSUE. I REPORTED TO (B)(6) WHERE I BOUGHT THEM BUT THEY DENIED EVERYTHING. I USE HYLO-GEL EYE DROPS AS WELL FOR RELIEF. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023014 SOLOTICA HIDROCOR LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL SOLOTICA INDUSTRIA E COMERCIO LTDA
    1023015 RENU SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN BAUSCH & LOMB INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other| R